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Book Summary
This highly readable text offers a pragmatic approach to the validation of
automated/computerized systems, an essential step for maintaining compliance
with global regulatory authorities, such as the FDA. It examines the different
levels of automated systems used throughout the drug development, manufacture,
and delivery life cycle, using the GAMP-4 life cycle approach to their
validation. Rich with case studies and real-life examples, it also supplies the
reader with true applications of GAMP 4 to different areas of regulations, such
as good laboratory practice, good clinical practice, good manufacturing
practice, and good data practice.
- ISBN-13
- 9780849323249
- Language
- English
- Binding
- Hard Bound
- Publisher
- Informa Healthcare
- Publishing Date
- 2005-08-03
- Total Pages
- 576
Validating Pharmaceutical Systems: Good Computer Practice In Life Science Manufacturing
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Product Specifications
Book Summary
This highly readable text offers a pragmatic approach to the validation of
automated/computerized systems, an essential step for maintaining compliance
with global regulatory authorities, such as the FDA. It examines the different
levels of automated systems used throughout the drug development, manufacture,
and delivery life cycle, using the GAMP-4 life cycle approach to their
validation. Rich with case studies and real-life examples, it also supplies the
reader with true applications of GAMP 4 to different areas of regulations, such
as good laboratory practice, good clinical practice, good manufacturing
practice, and good data practice.
Book Specifications
- ISBN-13
- 9780849323249
- Language
- English
- Binding
- Hard Bound
- Publisher
- Informa Healthcare
- Publishing Date
- 2005-08-03
- Total Pages
- 576